OBJECTIVE: To control the quality of Zhongfeng’an Koufuye, the TLC identification method of Astragalus membranaceus and Hirudo nipponica and the quantitative determination of astragaloside IV by TLCS are estabilished. METHODS: The sample was identified respectively by TLC in contrast with Astragalus memberanaceus and Hirudo nzpponica drugs after it is treated. First, the sample was placed on the diaion column and rinsed the substance of water and grease solubility out of the column with water and 400 ml·L-1 alcohol. Then the astragaloside IV was rinsed out of the column with 700 ml·L-1alcohol. The alcohol solution of astragaloside IV was collected and the alcohol was dried with water-bath. The remainder was dissolved and exactly diluted to 2 ml by methanol. Being dropped, spread and developed, the content was determined by TLCS at 530 nm. RESULTS: The TLC identification was highly specific and the spots were clear and concentrated. The quantitative method was simple, sensitive, reproducible and accurate. The average recovery of astragaloside IV in the sample was 98.38%(n=5).The relative standard deviation was 1.07%. CONCLUSION: The quality standard was able to effectively control real quality of Zhongfeng'an Koufuye.